Percutaneous Needle Electrolysis (PNE) in Soleus Injury

Effect of the Application of Ultrasound-guided Percutaneous Needle Electrolysis on the Chronic Soleus Injury in Dancers

This study evaluates if the physiotherapy treatment based on eccentric exercise, ultrasound-guided PNE or a combination of both therapies on chronic soleous injuries may cause changes in pain, functionality, dorsal flexion of the foot, balance and muscle fatigue in dancers.

Study Overview

• Status: Completed
• Conditions: Soleus Injury
• Intervention / Treatment: Other: Eccentric exercise; Other: PNE; Other: Combined

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Seville, Spain, 41009
    • University of Seville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 26 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Over 16 years.
• at least 5 years of formal dance training.
• at least 20 hours of training per week.
• Pain in the back of the leg
• diagnosis of chronic soleus injury

Exclusion Criteria:

• Unsurpassed fear of needles
• History of adverse reactions to needles
• Immune system disorder
• Difficulty expressing your feelings properly
• Epilepsy and / or allergies to metals.
• Other lower limbs pathology

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eccentric group; The dancers of this group wil perform a soleus eccentric exercise	Other: Eccentric exercise; soleus eccentric exercise
Experimental: PNE group; The dancers of this group will receive a PNE treatment, consisting of the application of galvanic current, by ultrasound. The approach will be performed with a transverse axis with a needle orientation that will depend on the location of the target tissue. The parameters will be 3 mA, 3 seconds, 3 impacts (3: 3: 3). The periodicity will be 1day/7day/21day	Other: PNE; the application of galvanic current
Experimental: Combined group; The dancers of this group will receive a combined treatment and will be carried out in the same way as the other two groups.	Other: Combined; soleus eccentric exercise and PNE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of pain level	Visual Analogue Scale (VAS: 0=no pain; 100= pain as bad as can be	Change from Baseline VAS at 3 months months
Change of Lunge Test	This test measures the ankle range of motion. Less than 9/10 cm, range of motion will be considered restricted	Change from Baseline lunge test at 3 months months
Change of the Releve test	During the unilateral balance test with open eyes, the participant will be asked to hold as much time as possible in the relay position (raised heel of the floor) on one leg	Change from Baseline releve test at 3 months months
Change of the Endurance test	The unilateral raised heel test. The dancer should repeatedly lift the heel from the floor to the maximum range of plantar flexion movement as many times as possible.	Change from Baseline endurance test at 3 months months
Change of the Balance test	The test will be conducted with closed eyes, flat feet and barefoot participants and dancers will perform a retiré position. Participants will maintain the position as long as possible.	Change from Baseline balance test at 3 months months
Changes of the DFOS questionnaire	This questionnaire measures the pain and function (0= bad; 90=well)	Change from Baseline DFOS questionnaire at 3 months months
Change of the Minimal Detectable Change (MCD)	The minimal detectable change is defined as a valid change in score that is not due to chance. Minimally clinically important difference (MCID), in comparison, goes beyond valid change to assess meaningful difference in dance function	Change from after treatment at 3 months months

Collaborators and Investigators

• Sponsor: University of Seville

Publications and helpful links

General Publications

• De-la-Cruz-Torres B, Barrera-Garcia-Martin I, Valera-Garrido F, Minaya-Munoz F, Romero-Morales C. Ultrasound-Guided Percutaneous Needle Electrolysis in Dancers with Chronic Soleus Injury: A Randomized Clinical Trial. Evid Based Complement Alternat Med. 2020 Aug 27;2020:4156258. doi: 10.1155/2020/4156258. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): November 1, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: July 27, 2019
• First Submitted That Met QC Criteria: July 30, 2019
• First Posted (Actual): August 1, 2019

Study Record Updates

• Last Update Posted (Actual): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 7, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: PNE in soleus

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No